FDA Clears Pfizer’s Lyrica for Spinal Cord Injury Neuropathic Pain

FDA approved Pfizer’s Lyrica® (pregabalin) capsules for the management of neuropathic pain associated with spinal cord injury. The drug is already cleared for various indications in 120 countries, and in the U.S. is approved for managing diabetic nerve pain, postherpetic neuralgia, fibromyalgia, and partial onset seizures in adult epilepsy patients who take one or more drugs for their condition.

Pfizer says over about 40% of the 270,000 patients with spinal cord injury in the U.S. suffer from related neuropathic pain. FDA’s clearance of Lyrica for the spinal cord injury neuropathic pain indication followed a priority review, and was based on data from two Phase III studies in 357 patients who were allowed to continue taking other pain medications including NSAIDs, opioids, and non-opioids. Data from the placebo-controlled 12- and 16-week trials showed that Lyrica therapy led to significant and continued reductions in neuropathic pain.

Lyrica was Pfizer’s second top-selling drug in calendar 2011, achieving revenues of $3.7 billion, up 21% on 2010.